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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216091
Company: MSN

Products on ANDA 216091

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZIPRASIDONE MESYLATE	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER;INTRAMUSCULAR	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216091

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216091

ZIPRASIDONE MESYLATE

POWDER;INTRAMUSCULAR; EQ 20MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GEODON	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER;INTRAMUSCULAR	Prescription	Yes	AP	020919	VIATRIS
ZIPRASIDONE MESYLATE	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER;INTRAMUSCULAR	Prescription	No	AP	211908	GLAND PHARMA LTD
ZIPRASIDONE MESYLATE	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER;INTRAMUSCULAR	Prescription	No	AP	216091	MSN

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